Freezing-drying method for live vaccine

A drying method, vacuum freeze-drying technology, applied in the direction of drying solid materials, drying solid materials without heating, drying, etc., can solve the problems of unstable quality, large loss of potency, high rejection rate, and achieve uniform sublimation rate. Effect

Active Publication Date: 2018-01-05
SICHUAN HUAPAI BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the above-mentioned deficiencies in the prior art, the present invention provides a freeze-drying method for live vaccines, which can effectively solve the problems of poor physical properties, large potency loss, unstable quality, waste products, etc. High rate defects

Method used

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  • Freezing-drying method for live vaccine

Examples

Experimental program
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Effect test

Embodiment 1

[0030] A freeze-drying method of swine transmissible gastroenteritis and epidemic diarrhea virus dual live vaccine, including the following steps: two transmissible gastroenteritis (SCJY-1 strain) and epidemic diarrhea virus (SCSZ-1 strain) The seed virus solution is added to the seedling tank, the temperature in the tank is controlled at 10°C, the tank is stirred evenly, the heat-resistant protective agent is added, and the stirring is continued, and then divided into 10ml vials of 2.6ml each. While filling, the temperature of the slab is controlled at about 0℃; after filling, the machine will automatically half stopper, and then put the filling product into the pumping tray and send it into the freeze-drying box in time, close the door, and use 10 minutes Time to reduce the temperature of the layer fluid of the vacuum freeze dryer to -43℃, keep it for 5h, and then start vacuuming, when the vacuum degree reaches below 15Pa, start to heat up; when the partition temperature rises...

Embodiment 2

[0033] A freeze-drying method of swine transmissible gastroenteritis and epidemic diarrhea virus dual live vaccine, including the following steps: two transmissible gastroenteritis (SCJY-1 strain) and epidemic diarrhea virus (SCSZ-1 strain) The seed virus solution is added to the seedling tank, the temperature in the tank is controlled at 10°C, the tank is stirred evenly, the heat-resistant protective agent is added, and the stirring is continued, and then divided into 10ml vials of 2.6ml each. While filling, the temperature of the slab is controlled at about 0℃; after filling, the machine will automatically half stopper, and then put the filling product into the pumping tray and send it into the freeze-drying box in time, close the door, and use 10 minutes Time to reduce the temperature of the layer fluid of the vacuum freeze dryer to -23°C and keep it for 1.5h; cool the product at a rate of 1°C / h to -25°C; adjust the temperature in the vacuum freeze dryer to -43°C and keep it ...

Embodiment 3

[0036] A freeze-drying method of swine transmissible gastroenteritis and epidemic diarrhea virus dual live vaccine, including the following steps: two transmissible gastroenteritis (SCJY-1 strain) and epidemic diarrhea virus (SCSZ-1 strain) The virus solution is added to the seedling tank, the temperature in the tank is controlled at 10°C, the tank is stirred evenly, the heat-resistant protective agent is added, and the stirring is continued, and then divided into 10ml vials of 2.6ml each. While filling, the temperature of the slab is controlled at about 0℃; after filling, the machine will automatically half stopper, and then put the filling product into the pumping tray and send it to the freeze-drying box in time, close the door, and use 10 minutes Time to reduce the temperature of the layer fluid of the vacuum freeze dryer to -16°C and keep it for 2h; then cool the product at a rate of 1°C / h to -25°C; adjust the temperature in the vacuum freeze dryer to -43°C and keep it 3h,...

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Abstract

The invention discloses a freezing-drying method for live vaccine. The freezing-drying method comprises the steps that the eutectic point range of a to-be-frozen and to-be-dried vaccine is tested, then, the live vaccine is placed in a vacuum freezing-drying machine pre-cooled to 0+/-1 DEG C, when the temperature of a plate layer of the vacuum freezing-drying machine is reduced to be higher than the eutectic point of the live vaccine by 1-2 DEG C, the current state is kept for 1-2 h, and continuous cooling is conducted with the rate of 1 DEG C/h till all vaccine is frozen; and cooling is immediately conducted to the temperature needed for sublimation, and finally vacuum sublimation is conducted according to the normal procedure. The product obtained through the method is not provided with large ice crystals, sublimation is easy, and after freezing-drying, a good product physical behavior can be obtained, and the freezing-drying titer losses are minimal.

Description

Technical field [0001] The invention belongs to the technical field of vaccine cryopreservation, and specifically relates to a freeze-drying method of live vaccines. Background technique [0002] Porcine epidemic diarrhea and porcine transmissible gastroenteritis are widespread worldwide, especially in Asian countries such as Korea, Japan and China. Porcine epidemic diarrhea and porcine transmissible gastroenteritis can reduce the survival rate of pigs, poor orderliness, slower growth, reduced weight gain, postpone the time to market, reduce feed utilization, increase additional consumption, and reduce their immunity. Increased susceptibility to bacteria and viruses, increased morbidity, dehydration, shock and even death, etc., have brought serious economic losses to the pig industry. [0003] In order to effectively control swine epidemic diarrhea and swine transmissible gastroenteritis, China has developed a dual live vaccine for the prevention and treatment of two diseases, but...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): F26B5/06A61K39/225A61K39/215A61P31/14
Inventor 吴越李宇周应辉万成燕池波邱良栋
Owner SICHUAN HUAPAI BIO PHARMA
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